Step 1: Contact the WECP Director
Please consult with Ann Lauritzen, Director of WECP, in the early stages of planning your research, prior to submitting your proposal to the Waisman Center Clinical Translational Core (CTC) and finalizing your IRB proposal to determine project feasibility and suitability. Factors to consider include, but are not limited to, availability of the study population (i.e., does WECP serve the population described?); proposed timeline; impact on space, resources, and staff; and alignment with the Waisman Center, UCEDD, and WECP mission and policies.
Ann can provide information about the WECP structure, including classroom schedules, characteristics of children enrolled in the program, and assess how many children in the program will meet your inclusion criteria. She can provide templates and advice for designing “parent friendly” recruitment materials and consent forms that meet WECP requirements. Ann can also assist with determining the best age range of children to recruit based on the methods/procedures proposed, as well as provide feedback about projects that may not be feasible given the demands on the program.
Step 2: Proposal Submission and Review
Submit a completed WECP Research Proposal to the CTC at email@example.com. The CTC research coordinator will forward the proposal for review by the CTC Director, UCEDD Research Director, and WECP Director to determine project feasibility and suitability. The investigator will receive feedback within 1-2 weeks regarding the timeline for proposal review. The CTC research coordinator will communicate to the investigator the outcome of the proposal review: endorsed, endorsed pending IRB approval or revisions, or declined.
Decisions to endorse proposals are made on a case-by-case basis. Factors considered in determining project feasibility and suitability include, but are not limited to: impact on school space, resources, schedule, student experience, and staff; scientific merit; availability of the study population; proposed timeline; and alignment with the Waisman Center mission and WECP priorities, policies and procedures.
The investigator may be invited to answer questions and provide clarifications in an effort to facilitate the process. If he or she is unable to respond, another member of the study team may do so as long as that individual is familiar with the study and is qualified to address concerns.
In cases when the outcome of the review is ‘endorsed pending revisions’ the investigator will revise and re-submit the proposal form, as needed, and forward the final version to the CTC research coordinator.
Step 3: UW-Madison IRB Approval
The investigator applies for IRB approval of the endorsed procedures and sends a copy of the IRB approval notice to the CTC research coordinator.
Step 4: Set-up and Implementation
Once the investigator obtains UW-Madison IRB approval for the protocol endorsed in Phase 3, the CTC research coordinator will work with the investigator and WECP to determine a timeline and facilitate implementation of the approved research protocol.
Prior to implementation of the activities, the following must be completed:
- Caregiver Background Checks: All research staff who will have direct contact with the WECP students must complete and submit Background Information Disclosure forms to the CTC research coordinator. The WECP is licensed as a group daycare center in the State of Wisconsin. The Wisconsin Caregiver Background Check Law, licensure requirements and WECP policy dictate that Background Information Disclosure forms and a state criminal history background check must be completed annually for all individuals who have personal contact with children at the center. The cost for background checks is billed to the investigator (see Rates).
- One-time fingerprint-based criminal background check: After January 1, 2016 a one-time fingerprint-based criminal background check is required (s. 48.685(1)(av), Wis. Stats) for all staff/volunteers who will have direct contact with WECP students. If completed, this check fulfills the requirements for the Caregiver Background Check (described above). All research staff should arrange with the CTC research coordinator to schedule a Fieldprint LiveScan Appointment, as the CTC holds a DOJ Record Check Account established for billing purposes and is approved to receive fingerprint-based background check results. The cost for fingerprint-based criminal background checks is billed to the investigator (see Rates).
- Mandated reporter online training: All UW staff (including research assistants an student volunteers working with children and parents) are mandated reporters by executive order #54. The training is available here: http://wcwpds.wisc.edu/mandatedreporter/. Each research team member who will have direct contact with the WECP students must submit the certificates of training to the CTC Research Coordinator.
- Physical Access: Physical access to the WECP is restricted to authorized persons. The authorizations required depend on a variety of factors. The CTC research coordinator will help you to determine the appropriate authorizations needed for your study team members.
After all background checks are completed, Ann Lauritzen will arrange an introduction to classroom personnel. Each classroom has a contact person with whom investigators should make arrangements to meet. All project staff should spend some time in the classroom prior to initiating data collection to become familiar to the children, such as reading during story hour (and vice versa). If necessary, a ‘field trip’ to the lab space will be arranged. Be advised that it is WECP policy that when research is carried out in a separate room from the classroom, two adults must be present with the student at all times.
The study team will be responsible for submitting the recruitment materials (e.g., cover letter, consent forms, HIPAA authorization forms (if applicable), study brochure, return forms, return envelopes). The CTC research coordinator will work with the WECP to distribute the materials as outlined in the approved proposal.
The CTC research coordinator will monitor progress and provide support throughout the project, as needed. The investigator should notify the CTC research coordinator of any changes in IRB approval dates, and keep the CTC research coordinator abreast of modifications that impact the WECP research collaboration.
Step 5: Share Results
Prior to publication of findings, please submit a summary of research findings to the CTC. This summary may be provided to WECP staff and families. Investigators are also encouraged to discuss their project and findings as part of the Early Childhood Seminar Series.